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Senior Specialist  IT Quality Audit - India  

MSD (company)

Posted on : 22 April 2017

Project Description

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy. Company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
  • The Senior Specialist of IT Audits will conduct both internal and external (vendor) audits as determined by a risk-based selection process, compliance exposures and business drivers within Merck s Manufacturing Division (MMD).  This role will drive continuous improvement by proactively identifying, scoping and auditing manufacturing computer systems that potentially affect patient safety, product quality, and data integrity.
  • Conducts computer system audits of GMP systems/operations to ensure compliance with prevailing regulatory laws and company policies through the computer system life-cycle.
  •  Conducts remote assessments and on-site vendor audits in support of the procurement and life-cycle monitoring of computerized system software and third party IT services.
  •  Responsible for the audit planning, audit execution and formal reporting of all audit results to the responsible management. 
  • Ensure responses to each audit observation is obtained and that appropriate remediation and corrective or preventive actions are taken and tracked to closure.
  •  Presents the results of audits to senior site and divisional management, including practical recommendations to address identified risks; requiring strong negotiation and influence skills.
  •  Supports the development of the GMP computerized system internal and external audit programs inclusive of procedure creation, audit tools and training delivery.
  •  Supports the annual development and maintenance of a risk-based audit plan/schedule including scope definition.
  •  Provides GMP computerized system quality and compliance consultancy and expertise to colleagues.
  •  Supports the analysis of quality and compliance data in order to identify and lead targeted continuous improvement efforts to improve operational process effectiveness through timely investigations and effective CAPA.
  •  Monitors trends, identifies compliance issues and determines opportunities for quality improvements within customer areas.
  •  Requests applicable resources to support audit plans.
  •  Is responsible for ensuring delivery of high quality and timely audit information to appropriate levels of management.
  •  Ensures independent and non-biased role in working with quality and compliance functional area groups to prevent any audit conflicts of interest. 
  • Collaborates with quality and compliance colleagues, as appropriate, to assure adequate focus.
  •  Responsible for practical knowledge of current and emerging global guidelines and regulations, relevant regulatory approaches and actions to effectively develop and advance audit strategies.
  •  Limited supervision required in day-to-day activities.
  •  Requires approximately 50  75% domestic and International travel for up to two weeks in duration.

Education Minimum Requirement:
 Bachelor's degree in Science, Information Technology or equivalent IT experience related to IT Systems Development, Implementation and/or IT Operations.

Required Experience and Skills:
  •  5-7 years of auditing experience in a highly regulated environment. 
  • Must demonstrate extensive knowledge of the principles, theories and concepts of computerized system auditing for compliance to GMP regulations
  •  2-3 years of experience in delivering validated IT solutions or an application support or vendor oversight role
  •  Familiarity and practical experience in the implementation of quality systems in a pharmaceutical or biotechnology manufacturing environment.

Preferred Experience and Skills:
  •  2-3 years in a management role with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
  •  Good understanding of a IT technology operations
  •  CISA, CISP Certification and knowledge of frameworks established under COBIT and ITIL
  •  Six-Sigma Green Belt Certification

Job Segment:  Audit, Biotech, Medical, Pharmaceutical, CAPA, Finance, Science, Healthcare, Management                       

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